Relationship Between Platinum Levels in the Blood and Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00274885
First received: January 10, 2006
Last updated: December 2, 2011
Last verified: May 2007
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Purpose
RATIONALE: Learning about the relationship between platinum levels in the blood and neurotoxicity in patients receiving oxaliplatin may help plan treatment and may help patients live more comfortably.
PURPOSE: This phase IV trial is studying the relationship between platinum levels in the blood and neurotoxicity in patients who are receiving oxaliplatin for gastrointestinal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: oxaliplatin Procedure: management of therapy complications |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study of the Relationship Between the Rate of Residual Platinum in the Blood and the Incidence of Persistent Neurotoxicity in Patients Treated for Gastrointestinal Cancer With Oxaliplatin |
Resource links provided by NLM:
Genetics Home Reference related topics:
gastrointestinal stromal tumor
MedlinePlus related topics:
Anal Cancer
Cancer
Carcinoid Tumors
Esophageal Cancer
Esophagus Disorders
Liver Cancer
Pancreatic Cancer
Stomach Cancer
Drug Information available for:
Oxaliplatin
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Relationship between residual platinum levels in the blood and persistent neurotoxicity [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics [ Designated as safety issue: No ]
| Estimated Enrollment: | 58 |
| Study Start Date: | October 2005 |
OBJECTIVES:
Primary
- Determine the relationship between residual platinum levels in the blood and persistent neurotoxicity in patients receiving oxaliplatin for gastrointestinal cancer.
Secondary
- Determine the pharmacokinetics of oxaliplatin in these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive oxaliplatin IV over 2 hours. Treatment repeats every 2-3 weeks in the absence of disease progression or unacceptable toxicity.
Neurological function and platinum levels in the blood are assessed at baseline, after each course of oxaliplatin, and at the end of study treatment.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of gastrointestinal cancer
- Receiving or planning to receive 8 months of oxaliplatin-based chemotherapy
- No pre-existing neuropathy
- No CNS disease or cerebral metastases
PATIENT CHARACTERISTICS:
- WHO 0-1
- Life expectancy ≥ 12 weeks
- No biliary or gastro-duodenal obstruction
- No familial, social, geographical, or psychological condition that would preclude study treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No other concurrent drug or agent that is potentially neurotoxic
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274885
Locations
| France | |
| CHU de Grenoble - Hopital Michallon | Recruiting |
| Grenoble, France, 38043 | |
| Contact: Christine Rebischung 33-4-7676-5451 | |
| Centre Hospital Universitaire Hop Huriez | Recruiting |
| Lille, France, 59037 | |
| Contact: Mohamed Hebbar, MD 33-3-2044-5461 m-hebbar@chru-lille.fr | |
| Clinique Saint Jean | Recruiting |
| Lyon, France, 69008 | |
| Contact: Gerard Lledo 33-4-7878-1051 | |
| CHU Pitie-Salpetriere | Recruiting |
| Paris, France, 75651 | |
| Contact: Jean-Baptiste Meric, MD 33-1-4216-0471 jeanbaptiste.meric@psl.ap-hop-paris.fr | |
| Hopital Saint Antoine | Recruiting |
| Paris, France, 75571 | |
| Contact: Olivier Rosmorduc, MD, PhD 33-1-4928-2382 olivier.rosmorduc@sat.aphp.fr | |
| Hopital Tenon | Recruiting |
| Paris, France, 75970 | |
| Contact: Thierry Andre, MD 33-1-6177-0708 thierry.andre@tnn.ap-hop-paris.fr | |
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
| Study Chair: | Philippe Lechat | CHU Pitie-Salpetriere |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00274885 History of Changes |
| Other Study ID Numbers: | CDR0000454401, GERCOR-TAUROX, SANOFI-GERCOR-TAUROX, EU-20573 |
| Study First Received: | January 10, 2006 |
| Last Updated: | December 2, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
neurotoxicity carcinoma of the appendix recurrent anal cancer stage I anal cancer stage II anal cancer stage IIIA anal cancer stage IIIB anal cancer stage IV anal cancer localized extrahepatic bile duct cancer recurrent extrahepatic bile duct cancer unresectable extrahepatic bile duct cancer localized gallbladder cancer recurrent gallbladder cancer unresectable gallbladder cancer recurrent gastric cancer |
stage IV gastric cancer recurrent colon cancer recurrent rectal cancer recurrent esophageal cancer localized gastrointestinal carcinoid tumor metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor regional gastrointestinal carcinoid tumor gastrointestinal stromal tumor advanced adult primary liver cancer localized resectable adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer recurrent pancreatic cancer stage I pancreatic cancer |
Additional relevant MeSH terms:
|
Neurotoxicity Syndromes Gastrointestinal Neoplasms Nervous System Diseases Poisoning Substance-Related Disorders Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Oxaliplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013